India Regulatory Issues
India Regulatory Issues
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The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.
Publisher: Datamonitor Healthcare
- Description
- Contents
- Samples
The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.
Some of the major challenges faced by MNCs in India include compulsory licensing of patents, lack of regulatory data protection, government price control, narrow standards for patentability, and restrictions on foreign direct investment in the Indian pharmaceutical sector.
India has been one of the favored destinations for multinational pharmaceutical companies to conduct clinical trials in the last few years due to the availability of treatment-naive patients and a fast-growing contract research industry. However, this situation has changed due to recent amendments to clinical trial regulations, which are not favorable to the clinical trial sponsors. Hence, many multinational pharmaceutical companies based in the US and Canada have stopped their clinical trials in India and have moved them to other global locations.
TABLE OF CONTENTS
4 EXECUTIVE SUMMARY
5 DRUG APPROVAL PROCESSES
5 The General Directorate of Pharmaceuticals and Pharmacy is the key authority responsible for
new drug approvals in Turkey
6 Drug approval process in Turkey
10 Bibliography
13 INTELLECTUAL PROPERTY PROTECTION
13 Intellectual property bodies in Turkey
16 Data exclusivity
16 Drug counterfeiting
17 Bibliography
25 APPENDIX
25 About the author
25 Scope
25 Methodology
LIST OF FIGURES
6 Figure 1: India – key regulatory authorities and their responsibilities
13 Figure 2: India – key intellectual property regulatory authorities and their responsibilities
13 Figure 3: India – Intellectual Property Office organizational structure
15 Figure 4: India – drug patents filed and granted, 2007–12
LIST OF TABLES
17 Table 1: India – key drugs that have been denied patent protection or have had their patent revoked, 2009–13
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